A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
This study tests a new investigational drug called RO7446603 to see if it can safely treat diabetic macular edema (DME), a condition where fluid builds up in the macula of the eye due to diabetes, causing vision problems. The drug will be tested alone and in combination with two other existing eye medications. The study will measure how safe the drug is, how the body processes it, and how well it works at improving vision.
Key Objective:This trial tests whether RO7446603 can safely reduce fluid buildup in the eye and improve vision in people with diabetic macular edema.
Who to Consider:People with diabetic macular edema who want to participate in research testing a potential new treatment option should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12% * Macular thickening secondary to DME involving the center of the fovea \> 325 microns * Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters Exclusion Criteria: * Currently untreated DM or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1 * Uncontrolled blood pressure (BP) * Pregnancy or breastfeeding, or intention to become pregnant during the study * For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants * Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1 * Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1 * Any current or history of ocular disease other than